Identity
- Trade Name
- VISUCORE 500 Refractor EUDAMEDFDA UDI
- Generic Name
- Automated ophthalmic refractometer FDA UDI
- Device Name
- VISUCORE 500 Refractor EUDAMED
- Model / Reference
- 000000-2522-537 EUDAMEDFDA UDI
Identifiers
- Catalog Number
- 000000-2522-537 FDA UDI
- Primary DI / UDI-DI
- 04250668606052 EUDAMEDFDA UDI
- Basic UDI-DI
- 42506686-B01-VCR500R-5G EUDAMED
- FDA Product Code
- HKO FDA UDI
- EMDN Code
- Z12120199 OPHTALMOLOGY ASSESSMENTS AND DIAGNOSIS INSTRUMENTS – OTHER EUDAMED
- GMDN Term
- Automated ophthalmic refractometer FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA UDI
- Regulation Number
- 886.1760 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
Yes
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
VISUCORE 500 Refractor by Carl Zeiss Vision Gmbh — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 42506686-B01-VCR500R-5G | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Carl Zeiss Vision GmbH
- EUDAMED SRN
- DE-MF-000006173
Sources (2)
- EUDAMED a9adbb73-12a7-467c-9f89-bf6e9f677d46 61 fields · synced Jun 18, 2026
- FDA UDI 7e68a657-eba5-4b73-97cd-015f96fad6ca 35 fields · synced May 30, 2026